MIT Gesundheit
MIT Gesundheit GmbH is a company founded with the aim of offering competent management consultation and services in pharmaceutical quality and safety. They follow the principle of advising entrepreneurs and thinking entrepreneurially, providing tailored solutions in regulatory affairs, pharmacovigilance, quality management, and more. They support clients in developing, registering, and maintaining pharmaceutical, dietary supplement, and medical device products, ensuring compliance with high regulatory standards. Their mission is to enable customers to offer safe products successfully on the market through unbureaucratic and solution-oriented support.
Industries
Nr. of Employees
small (1-50)
MIT Gesundheit
Kleve, Schleswig-Holstein, Germany, Europe
Services
Modular PV services including system setup and maintenance, PSMF preparation, literature monitoring, case management, signal detection, periodic reporting (PSUR/PBRER), RMPs, product metadata registration and provision of legally required PV personnel.
Regulatory strategy, CTD/eCTD dossier authoring and conversion, submissions, variations and renewals, ASMF/CEP application support, regulatory due diligence and secure dossier archiving.
Design and implementation of QMS, quality assurance manuals, development and revision of SOPs, staff training, internal and supplier audits and remediation support.
Drafting of specialised contracts for pharmaceutical operations and implementation of contractual obligations into QMS and digital signature/approval workflows.
Support for company setup, portfolio exchanges, acting-as-MAH services and rapid market-entry strategies for clients without local presence.
Assessment of supplement marketability and permitted health claims, registration with national authorities, supply-chain coordination, translations and market monitoring.
Modular PV services including system setup and maintenance, PSMF preparation, literature monitoring, case management, signal detection, periodic reporting (PSUR/PBRER), RMPs, product metadata registration and provision of legally required PV personnel.
Regulatory strategy, CTD/eCTD dossier authoring and conversion, submissions, variations and renewals, ASMF/CEP application support, regulatory due diligence and secure dossier archiving.
Design and implementation of QMS, quality assurance manuals, development and revision of SOPs, staff training, internal and supplier audits and remediation support.
Drafting of specialised contracts for pharmaceutical operations and implementation of contractual obligations into QMS and digital signature/approval workflows.
Support for company setup, portfolio exchanges, acting-as-MAH services and rapid market-entry strategies for clients without local presence.
Assessment of supplement marketability and permitted health claims, registration with national authorities, supply-chain coordination, translations and market monitoring.
Expertise Areas
- Pharmacovigilance and drug safety systems
- Regulatory affairs and dossier lifecycle management
- Quality management systems and GxP SOP frameworks
- Clinical trial pharmacovigilance
Key Technologies
- eCTD dossier authoring and electronic archiving
- Regulatory adverse-event reporting systems and product master-data registries
- Pharmacovigilance case-management and safety databases
- Signal detection and benefit–risk analytics